inking protein profiles to disease progression and clinical expression in Parkinson*s disease: part two, longitudinal outcomes

Completed

Conditions: Parkinson
Parkinson's disease
10028037
10012272

Registration Number: NL-OMON47594

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

* Patients from the baseline cohort diagnosed with Parkinson*s disease according to the MDS Clinical Diagnostic Criteria for Parkinson*s Disease
* Mini-Mental State Examination (MMSE) score *18 at recruitment
* Being able to understand the aim of the study and the study procedure and give written informed consent

Exclusion Criteria

* A history of neurological disorders other than PD, that affect the central nervous system or are known to influence CSF proteins
* Unwillingness to be informed of unexpected medical findings;Potential subjects are eligible to participate in this study if they cannot undergo lumbar puncture due to the following reasons:
* No CSF collected at baseline
* Use of anticoagulants or a history of coagulation disorders
* Infected skin over the needle entry site for lumbar puncture
* Signs of raised intracranial pressure
* Travelling to the VUmc outpatient clinic is too burdensome
* Unwillingness to undergo lumbar puncture
These subjects we will undergo all study procedures with the exception of CSF collection.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* UPDRS III score (T1-T0)<br /><br>* MMSE score (T1-T0) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Hoehn and Yahr stage (T1)<br /><br>* Test scores representing the five most affected cognitive domains in PD<br /><br>(attention, executive function, memory, visuospatial function and language)<br /><br>(T1)<br /><br>* Presence of PD mild cognitive impairment (PD-MCI) and PD dementia (PD-D)<br /><br>according to the MDS diagnostic criteria (T1)<br /><br>* Activity of Daily Living (T1): UPDRS part II, Schwab and England ADL scale<br /><br>* CSF and blood-based biomarker concentration (T1)<br /><br>* Predefined genetic factors associated with cognitive decline in PD<br /><br>* Test scores for neuropsychiatric symptoms in PD (T1): SCOPA<br /><br>Psychiatrische Complicaties (SCOPA-PC), Beck Depression Inventory, Beck Anxiety<br /><br>Inventory</p><br>